meddevicedb.com FDA Device Reference

esolution

DEN230006 Class II Direct
Decision Date
2023-09-06
Sponsor / Applicant
S4 Medical Corp.

Technical Specification

510(k) Submission ID DEN230006
Product Code QXU
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5710
Decision Date 2023-09-06
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

esolution received FDA 510(k) clearance under submission number DEN230006, sponsored by S4 Medical Corp.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-09-06.

Classification & Regulation

This clearance is catalogued under FDA product code QXU and 21 CFR 870.5710, within the Cardiovascular review panel as a Class II device.